PracticeUpdate: Cardiology - Winter 2018

Drs. Doug Zipes and Jared Bunch Discuss the CABANA Trial EXPERT OPINION 20

Dr. Doug Zipes, Editor-in-Chief of PracticeUpdate Cardiology , recently interviewed Dr. Jared Bunch on the CABANA trial. Dr. Bunch is the Medical Director of Electrophysiology for Intermountain Healthcare at Intermountain Heart Institute, Intermountain Medical Center in Murray, Utah.

Dr. Zipes: Jared, you participated in this very important prospective randomized trial called CABANA, testing the impact of catheter ablation in patients with atrial fibrilla- tion. Could you give us a brief outline of the trial itself before we get into the specifics of the results? Dr. Bunch: CABANA is a randomized trial of approximately 3000 patients over the age of 65 with more than one risk factor for stroke comparing catheter ablation as an upfront rhythm control approach versus anti-arrhythmic drug therapy. It was designed, initially, to look at mortality as the primary endpoint. A few years into the trial the DSMB (Data and Safety Monitoring Board) came back to recommend a change in the primary endpoint, due to slower than anticipated enrollment and a slower than anticipated event rate, to make a composite endpoint of death, disa- bling stroke, serious bleeding, and cardiac arrest. These patients were followed with a goal of approximately 5 years. Secondary endpoints included freedom from atrial fibrillation and cardiovascular hospi- talization, and then looking specifically at mortality versus cardiovascular mortality. There are also additional study arms that are yet to be reported. For example, Dan Marks at Duke will report the economic analysis of catheter ablation compared with antiarrhyth- mic drug therapy and Dawood Darbar from University of Illinois, Chicago, will report on the CABANA gene project. Dr. Zipes: The initial results of CABANA were presented by the PI (Principal Investigator), Doug Packer, on behalf of all of the investigators at the Heart Rhythm Society meeting in Boston in May 2018, and they stirred up a great deal of interest and some contro- versy since the differences between an intention-to-treat analysis and an on-treatment analysis were pretty important. Describe for us the initial observations with the inten- tion-to-treat analysis. Dr. Bunch: When CABANA was initially designed, the hope was that a single effective therapy may interrupt the natural history of atrial fibrillation and its comorbidities beyond known benefits, such as improving quality of life and time spend in sinus rhythm. In

Dr. Doug Zipes

Dr. Jared Bunch

PRACTICEUPDATE CARDIOLOGY